Trial Outcomes & Findings for Reasoning Training in Individuals With Bipolar Disorder (NCT NCT02843282)

NCT ID: NCT02843282

Last Updated: 2024-12-06

Results Overview

Complex abstraction subtest: After reading a complex text, participants generate a high-level synthesis of abstracted ideas (versus recall of concrete details). \[raw scores, min value = 0, max value = 10, higher indicates better performance\]

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: Pre and within 2 weeks post intervention
• Results posted on: 2024-12-06

Participant Flow

No enrolled participants were excluded from the training

Participant milestones

Measure	Cognitive Training Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reasoning Training in Individuals With Bipolar Disorder

Baseline characteristics by cohort

Measure	Cognitive Training n=27 Participants Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Age, Continuous	45.8 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre and within 2 weeks post intervention

Complex abstraction subtest: After reading a complex text, participants generate a high-level synthesis of abstracted ideas (versus recall of concrete details). [raw scores, min value = 0, max value = 10, higher indicates better performance]

Outcome measures

Measure	Cognitive Training n=27 Participants Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Change From Baseline: Test of Strategic Learning pre	2.35 score on a scale Standard Error 0.32
Change From Baseline: Test of Strategic Learning post	3.04 score on a scale Standard Error 0.32

SECONDARY outcome

Timeframe: Pre and within 2 weeks post intervention

Participants are provided with two words/concepts and must state how they are alike; [scaled scores, min value = 0, max value = 19, higher indicates better performance]

Outcome measures

Measure	Cognitive Training n=27 Participants Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Change From Baseline: Wechsler Adult Intelligence Scale (WAIS), Similarities Subtest pre	12.63 score on a scale Standard Error 0.40
Change From Baseline: Wechsler Adult Intelligence Scale (WAIS), Similarities Subtest post	13.62 score on a scale Standard Error 0.41

SECONDARY outcome

Timeframe: Pre and within 2 weeks post intervention

Participants must sort a set of cards into as many groups as possible, based on certain parameters. This score reflects the correct number of sorts generated. [scaled scores, min value = 0, max value = 19, higher indicates better performance]

Outcome measures

Measure	Cognitive Training n=27 Participants Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Card Sorting pre	11.70 score on a scale Standard Error 0.42
Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Card Sorting post	13.56 score on a scale Standard Error 0.42

SECONDARY outcome

Timeframe: Pre and within 2 weeks post intervention

Participants must recite number sequences in reverse order; [scaled scores, min value = 0, max value = 19, higher indicates better performance]

Outcome measures

Measure	Cognitive Training n=27 Participants Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Change From Baseline: Working Memory (Digits Backwards) pre	6.78 score on a scale Standard Error 0.36
Change From Baseline: Working Memory (Digits Backwards) post	7.30 score on a scale Standard Error 0.36

SECONDARY outcome

Timeframe: Pre and within 2 weeks post intervention

Participants must either state color of word or read the word presented; [scaled scores, min value = 0, max value = 19, higher indicates better performance]

Outcome measures

Measure	Cognitive Training n=27 Participants Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Color-Word, Inhibition & Switching Subtest pre	11.04 score on a scale Standard Error 0.37
Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Color-Word, Inhibition & Switching Subtest post	11.46 score on a scale Standard Error 0.37

SECONDARY outcome

Timeframe: Pre and within 2 weeks post intervention

Participants connect letters and numbers in ascending order as quickly as they can; [raw score in seconds, min value = 0, max value = 200, lower indicates better performance]

Outcome measures

Measure	Cognitive Training n=27 Participants Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Change From Baseline: Divided Attention pre	73.44 seconds Standard Error 5.43
Change From Baseline: Divided Attention post	66.86 seconds Standard Error 5.48

SECONDARY outcome

Timeframe: Pre and within 2 weeks post intervention

Participants had to generate as many words as possible in one minute that fit task parameters; [scaled scores, min value = 0, max value = 19, higher indicates better performance]

Outcome measures

Measure	Cognitive Training n=27 Participants Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Change From Baseline: Verbal Fluency pre	11.30 score on a scale Standard Error 0.61
Change From Baseline: Verbal Fluency post	11.82 score on a scale Standard Error 0.61

SECONDARY outcome

Timeframe: Pre and within 2 weeks post intervention

Participants are asked to recall a list of words they heard 20 minutes earlier; [raw scores, min value = 0, max value = 15, higher indicates better performance]

Outcome measures

Measure	Cognitive Training n=27 Participants Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Change From Baseline: Rey Auditory Verbal Learning Test (RAVLT) pre	9.70 score on a scale Standard Error 0.68
Change From Baseline: Rey Auditory Verbal Learning Test (RAVLT) post	10.93 score on a scale Standard Error 0.68

SECONDARY outcome

Timeframe: Pre and within 2 weeks post intervention

Participants are asked to recall the details of a story they were read 20 minutes earlier; [scaled scores, min value = 0, max value = 19, higher indicates better performance]

Outcome measures

Measure	Cognitive Training n=27 Participants Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Change From Baseline: Logical Memory pre	11.89 score on a scale Standard Error 0.72
Change From Baseline: Logical Memory post	12.26 score on a scale Standard Error 0.72

SECONDARY outcome

Timeframe: Pre and within 2 weeks post intervention

Participants fill out a self-report questionnaire assessing different domains of quality of life; [raw score; min value = 0, max value = 280, higher score indicates higher reported quality of life]

Outcome measures

Measure	Cognitive Training n=27 Participants Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Change From Baseline: Quality of Life in Bipolar Disorder (QoL.BD) pre	176.93 score on a scale Standard Error 6.90
Change From Baseline: Quality of Life in Bipolar Disorder (QoL.BD) post	183.93 score on a scale Standard Error 7.00

SECONDARY outcome

Timeframe: Pre (from baseline) and within 2 weeks post intervention

Population: Only for participants who participated in brain imaging portion of study (only for participants that were eligible for MRI)

Mean-level change in resting state relative cerebral brain blood flow (rCBF) in left Inferior frontal gyrus (min value = 0, max value = 2, lower value indicates decreased cerebral blood flow and higher indicates increased cerebral blood flow)

Outcome measures

Measure	Cognitive Training n=12 Participants Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Resting State Relative Cerebral Brain Blood Flow (rCBF) pre	0.67 score on a scale Standard Deviation 0.11
Resting State Relative Cerebral Brain Blood Flow (rCBF) post	0.82 score on a scale Standard Deviation 0.10

SECONDARY outcome

Timeframe: Pre and within 2 weeks post intervention

Participants must sort a set of cards into as many groups as possible, based on certain parameters, and state why it is an accurate sort. This score reflects the accuracy of the sort description. [scaled scores, min value = 0, max value = 19, higher indicates better performance]

Outcome measures

Measure	Cognitive Training n=27 Participants Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Accurate Description of Sorts post	12.96 score on a scale Standard Error 0.43
Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Accurate Description of Sorts pre	11.74 score on a scale Standard Error 0.43

SECONDARY outcome

Timeframe: Pre and within 2 weeks post intervention

After proctor has sorted cards, participants must state why sort is accurate/how cards are alike. [scaled scores, min value = 0, max value = 19, higher indicates better performance]

Outcome measures

Measure	Cognitive Training n=27 Participants Advanced reasoning training Advanced Reasoning Training: This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Accurate Recognition of Sorts pre	11.56 score on a scale Standard Error 0.47
Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Accurate Recognition of Sorts post	12.89 score on a scale Standard Error 0.47

Adverse Events

Cognitive Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Erin Venza, Research Clinician

University of Texas at Dallas, Center for BrainHealth

Phone: 972-883-3208

Email: erin.venza@utdallas.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place